Efficacy of Pioglitazone and Fortamet Combination Therapy in Subjects With Type 2 Diabetes
- Conditions
- Diabetes Mellitus
- Interventions
- Registration Number
- NCT00754403
- Lead Sponsor
- Takeda
- Brief Summary
The purpose of this study is to determine the efficacy of pioglitazone and metformin combination therapy, once daily (QD), on glycosylated hemoglobin in adults with type 2 diabetes.
- Detailed Description
Pioglitazone (ACTOS®) is a member of a class of oral antidiabetic agents known as thiazolidinediones. The insulin-sensitizing actions of thiazolidinediones are at least partially mediated through the peroxisome proliferator-activated receptor gamma. These receptors are found primarily in adipocytes, vascular endothelial cells, monocytes, hepatocytes, and to a lesser extent myocytes.
Metformin was developed as an extended-release formulation of metformin hydrochloride and designed for once-a-day oral administration. Metformin is an antihyperglycemic agent, which improves glucose tolerance in patients with, type 2 diabetes, lowering both basal and postprandial plasma glucose.
On 15 July 1999, the FDA approved pioglitazone for use as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes. Pioglitazone is indicated for monotherapy and for use in combination with sulfonylureas, metformin, or insulin when diet and exercise plus the single agent do not result in adequate glycemic control. On 26 November 2003, the FDA approved the combined use of pioglitazone with metformin.
This study is designed to evaluate the effect on glycemic control when pioglitazone and metformin are taken together. Individuals participating in this study will provide written informed consent and will be required to commit to a screening visit and approximately 5 additional visits at the study center. Study participation is anticipated to be about 31 weeks (or approximately 8 months). Multiple procedures will occur at each visit which may include fasting, blood collection, urine collection, physical examinations and electrocardiograms.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 312
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Metformin 1000 mg QD Metformin - Pioglitazone 30 mg QD + Metformin 1000 mg QD Pioglitazone and metformin -
- Primary Outcome Measures
Name Time Method Change from randomization in Glycosylated Hemoglobin Final Visit
- Secondary Outcome Measures
Name Time Method Change from randomization in Fasting Plasma Glucose Final Visit Change from randomization in Insulin Final Visit Change from randomization in Pro-Insulin Final Visit Change from randomization in Homeostasis Model Assessment Final Visit Change from randomization in Triglycerides Final Visit Change from randomization in Total Cholesterol Final Visit Change from randomization in Low-Density Lipoprotein Cholesterol Final Visit Change from randomization in high-density Lipoprotein Cholesterol Final Visit Change from randomization in Lipid Fractionation Final Visit Change from randomization in High Sensitivity C-Reactive Protein Final Visit Change from randomization in Creatine Phosphokinase Final Visit